Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Arterial Disease
Completed
Conditions studied: Peripheral Arterial Disease
In brief
Treatment with paclitaxel-based endovascular devices (PED) has become a common treatment option for patients with peripheral artery disease (PAD) involving the femoral-popliteal artery. However, an aggregate level meta-analysis identified an association between the use of PED and increased all-cause mortality at both two and five-year follow-up intervals, though there are significant limitations of these analyses. Exploration of real-world data has been suggested as a means to further investigate the safety of PED. The current study explores the association of PED and mortality in real-world data using U.S. commercial claims from the FAIR Health data warehouse.
Key facts
- Study ID
- NCT04647643
- Run by
- Lahey Clinic
- People needed
- 8000
- Starts
- 2020-11-20
- Expected to finish
- 2021-12-31
- Last updated by the study team
- 2022-02-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients, age 18 or older, who had a health insurance claim for outpatient endovascular treatment of the femoral or popliteal arteries for symptomatic PAD will be included. The diagnosis and treatment of PAD in the femoral and popliteal arteries will be identified by CPT/HCPCS and ICD-9 and ICD-10 PCS codes.
- Presence of at least one additional outpatient or inpatient claims, at least 12 months following the index procedure, in order to demonstrate continued enrollment in health insurance coverage.
You may not qualify if…
- Age <18 years
- No qualifying peripheral arterial endovascular procedure
- Inpatient procedure
- Patients without any linked claim record more than 12 months after the index procedure, not known to have died or entered hospice care within the first 12 months
Where it is running
- Lahey Clinic, Inc — Burlington, Massachusetts, United States
Full record on ClinicalTrials.gov
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